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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePASSIVE PLUS/ISOFLEX S&P/ISOFELX OPTIM FAMILIES OF LEADS
Classification Namepermanent defibrillator electrodes
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS025
Date Received01/30/2009
Decision Date02/27/2009
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate semi-automated packaging process.
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